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WARNING

Melphalan should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous (IV) to oral melphalan have shown more myelosuppression with the IV formulation. Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the IV formulation. Melphalan is leukemogenic in humans. Melphalan produces chromosomal aberrations in vitro and in vivo and, therefore, should be considered potentially mutagenic in humans.

SUMMARY

ALKERAN®(melphalan hydrochloride)for Injection

ALKERAN (melphalan), also known as L-phenylalanine mustard, phenylalanine mustard, L-PAM, or L-sarcolysin, is a phenylalanine derivative of nitrogen mustard. Melphalan is a bifunctional alkylating agent which is active against selective human neoplastic diseases.

ALKERAN for Injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.

Three palonosetron regimens to prevent CINV in myeloma patients receiving multiple-day high-dose melphalan and hematopoietic stem cell transplantation. [2011.04]BACKGROUND: Explore safety and efficacy of three palonosetron-containing regimens for emesis prevention over 7 days in multiple myeloma (MM) patients receiving melphalan (100 mg/m(2)) and hematopoietic stem cell transplantation (HSCT)... CONCLUSIONS: Palonosetron with dexamethasone was safe and effective in preventing emesis in MM patients receiving melphalan and HSCT. This pilot study with a limited number of patients suggests that multiple doses of palonosetron could be more effective than a single dose in making patients emesis free without need for rescue medication. However, even multiple doses of palonosetron resulted in only 20% of patients being emesis free without rescue medication, suggesting that further improvement will require development of more effective combination antiemetic therapy. (c) The Author 2010. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

Melphalan and Amifostine Followed By One or Two Autologous or Syngeneic Stem Cell Transplants and Maintenance Therapy in Treating Patients With Stage II-III Multiple Myeloma [Recruiting]
RATIONALE: Giving chemotherapy drugs, such as melphalan, work in different ways to stop the
growth of cancer cells, either by killing the cells or by stopping them from dividing.
Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of
chemotherapy. Giving chemotherapy with a peripheral stem cell transplant once or twice,
using stem cells from the patient or an identical brother or sister, may allow more
chemotherapy to be given so more cancer cells are killed. Giving maintenance therapy after a
stem cell transplant may kill any cancer cells that remain. It is not yet known which dose
of melphalan is more effective in treating multiple myeloma (MM).

PURPOSE: This randomized phase III trial is studying two different doses of melphalan to
compare how well they work when given together with amifostine followed by one or two
autologous or syngeneic stem cell transplants and maintenance therapy in treating patients
with stage II-III MM

Busulfan Plus Melphalan Versus Melphalan [Recruiting]
The goal of this clinical research study is to compare Busulfex (busulfan) with or without
Alkeran (melphalan) to learn which study therapy may be better at helping to control MM in
patients who will receive an autologous stem cell transplant. The safety of this
combination therapy will also be studied.

Melphalan and busulfan are designed to damage the DNA (genetic material) of cells, which may
cause cancer cells to die.

PURPOSE: Phase I trial to study the effectiveness of melphalan and buthionine sulfoximine
followed by bone marrow or peripheral stem cell transplantation in treating children who
have resistant or recurrent neuroblastoma.